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Kola
Moderator
Username: Kola
Post Number: 1522
Registered: 02-2005
Rating: N/A
Votes: 0 (Vote!) | | Posted on Friday, June 17, 2005 - 04:25 pm: | 
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U.S. panel backs NitroMed heart drug for blacks
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By Lisa Richwine
GAITHERSBURG, Md. (Reuters) - The first medicine for patients of one particular race moved closer to U.S. approval on Thursday after an advisory panel endorsed a NitroMed Inc. heart failure pill for blacks.
NitroMed's novel bid to market the drug, BiDil, only for black patients sparked complaints from some doctors and ethicists who said there was no biological reason one race should respond differently than others.
But seven out of nine members of a Food and Drug Administration advisory panel said the drug should be cleared for use only in blacks because that was the group NitroMed studied, and the benefits were convincing. Many praised NitroMed for focusing on a group they said needed more attention in medical research.
"This was a courageous thing to do for a population that has a disproportionate burden of disease ... As a clinician, I find the evidence more than adequate for approval," said Dr. Steven Nissen, a Cleveland Clinic cardiologist and the panel's chairman.
African-Americans are more likely than others to develop heart failure and to die early from the disease, studies have found. In NitroMed's trial of 1,050 patients who identified themselves as black, BiDil reduced deaths by 43 percent.
If the FDA takes the panel's advice, which it usually does, BiDil would be the first drug to reach the market for Lexington, Massachusetts-based NitroMed.
An approval specifically for blacks would benefit NitroMed because the company holds patent rights for that use until 2020. The patent for BiDil for general use expires in 2007.
Even with an approval for blacks only, doctors could prescribe BiDil for anyone they thought it might help.
Some critics of NitroMed's plan said they felt BiDil would work in some people of other races or ethnic backgrounds and therefore should be approved for general use. Some of the critics argue that in the past, some drugs were studied only in white people but their approved uses were not limited.
"I don't find any justification for approving it only in one particular patient population," said Dr. Ronald Portman, a panel member and pediatric nephrologist at the University of Texas-Houston Medical School. Portman was one of two panelists who backed BiDil's approval but opposed singling out blacks.
"I think it was a very positive outcome," Jennifer Chao, an analyst with Deutsche Bank, said of the panel recommendation. Ahead of the meeting, Chao predicted annual BiDil sales would hit $270 million in 2008.
BiDil is a combination of two generic medicines -- isosorbide dinitrate and hydralazine -- that dilate blood vessels. It was designed to treat congestive heart failure, a progressive weakening that impairs the heart's ability to pump. About 750,000 African-Americans have been diagnosed with heart failure, NitroMed said. Half the people with heart failure die within five years of diagnosis.
Studies of BiDil in the 1980s did not show a benefit for patients overall, but researchers said blacks fared better than others.
NitroMed and the Association of Black Cardiologists then studied 1,050 advanced heart failure patients who identified themselves as black, and gave them standard drug therapy plus either BiDil or a placebo.
Deaths were so much lower in the BiDil group that researchers ended the study early so all patients could take BiDil. Fifty-four patients, or 10.2 percent, died in the placebo group, compared with 32 deaths, or 6.2 percent, in the BiDil group.
NitroMed said it expects a final decision from the FDA by June 23. Trading in the company's shares was halted on Nasdaq during the panel meeting.
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roXie
Unregistered guest
Rating: N/A
Votes: 0 (Vote!) | | Posted on Friday, June 17, 2005 - 07:57 pm: |
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It's pretty clear this drug was went through faulty experimenting. Who were the test subjects? Young adults? mature adults? elderly? poor? miidle class? What were their usual diets? These self-identified blacks, were they all american blacks or were some of them west indian or african? that would make a difference demographically.It's also obvious that those Black Cardiologists forgot to take into consideration the fact that some american blacks still eat soul food high in fat and sodium and that the working classes, and the younger generation in general, endure higher stresses in everday life. Personally I wouldn't take a drug that drips with racial pseudo-science. |
Kola
Moderator
Username: Kola
Post Number: 1524
Registered: 02-2005
Rating: N/A
Votes: 0 (Vote!) | | Posted on Friday, June 17, 2005 - 08:19 pm: |
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I have three comments--
(1) Why do Africans not have this problem with Heart Failure/Heart Disease?...yet we share the African disease "Sickle Cell" (I myself have sickle cell trait) with our diaspora of children.
(2) There was a recent AIDS drug that worked, miraculously, for BLACK patients--but not for most other races, with "ASIANS" being the second group to benefit the most.
The drug worked even better on Africans than it did on African-Americans.
(3) There was a famous Black Baseball player in America whose daughter needed a Kidney transplant (or some kind of organ transplant)---but the MOTHER was "Jewish", which caused a rare blood type that prevented the doctors from saving the daughter. The daughter died.
Does anyone else remember that?
_________
Apparently there IS a such a thing as "race".
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Cbd
Unregistered guest
Rating: N/A
Votes: 0 (Vote!) | | Posted on Friday, June 17, 2005 - 08:27 pm: |
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The drug has been approved.
http://www.nationalledger.com/scribe/archives/2005/06/fda_panel_votes_1.shtml |
Libralind2
"Cyniquian" Level Poster
Username: Libralind2
Post Number: 127
Registered: 09-2004
Rating: N/A
Votes: 0 (Vote!) | | Posted on Friday, June 17, 2005 - 08:48 pm: |
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While on this topic about drugs, I have a nerve problem in my foot. The pain is deep and severe. It feels like a knive going up through my arch with needles on the tip of the knife when I walk. When sitting it just throbs. AND it is not gout. Ive been to the doctor and she put me on B6. Its not going to work quickly enough to give me relief. I cried all the way to work this morn, even when I stopped to get Advil for pain as the 600MG IBP they prescribed doesnt help. Has anyone had this issue or know of anyone with nerve problems and what did they do for it. Someone also told me I might need a chiropractor.
LiLi |
Kola
Moderator
Username: Kola
Post Number: 1527
Registered: 02-2005
Rating: N/A
Votes: 0 (Vote!) | | Posted on Friday, June 17, 2005 - 08:54 pm: |
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Lili, you probably have "heel spurs"
which comes with age and
which requires surgery
---I know, because I work out a lot since I passed (or think I passed) 35 and I had a few friends to develop it.
If you email me your phone number, I can put you in touch with a friend who had it BAD. I don't know what drugs she took. But I know how to get the necessary drugs to you from out of the country if it's that bad and you can't get surgery right away.
Kolaboof_email@yahoo.com
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roXie
Unregistered guest
Rating: N/A
Votes: 0 (Vote!) | | Posted on Friday, June 17, 2005 - 10:15 pm: |
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To Kola:
--(1) Why do Africans not have this problem with Heart Failure/Heart Disease?...yet we share the African disease "Sickle Cell" (I myself have sickle cell trait) with our diaspora of children.--
well, the sickle cell trait developed from regions where malaria was common-- in other words the medditeranean,and northern and western africa. Most AA are of distant western or northern african descent,if I recall, aren't YOU of northern african decent?
--There was a recent AIDS drug that worked, miraculously, for BLACK patients--but not for most other races, with "ASIANS" being the second group to benefit the most.--
We all have become different "races" as a result of physical evolutionary adaptation during human migration.If there is a factor in the differing affects in certain groups, it is due to the adaptive biological functions that we still carry over from those pre-historic ancestors. For ex, andean indians have larger chests to breathe the thin mountain air, the chukchi of Russia have thicker builds to retain body heat, and white people sunburn in the tropics. ;)As a result, certain group's anatomies can handle certain things while others can't, drugs being one of them.
--The drug worked even better on Africans than it did on African-Americans.--
I thought I made a point about ethnic demographics.
--There was a famous Black Baseball player in America whose daughter needed a Kidney transplant (or some kind of organ transplant)---but the MOTHER was "Jewish", which caused a rare blood type that prevented the doctors from saving the daughter. The daughter died.--
I don't understand your connection here. The girl having a rare blood type while coincidently being bi-racial doesn't offer proof to race. two different races, "mixed" or "unmixed", can have the same blood type. People of ANY race can have a rare blood type, and it is hereditary so the girl could have inherited it from either side of her family. And the fact it is RARE was probably the reason the girl died.
I do recall local story by my way about a white woman who donated her kidney to her black co-worker, and (guess what?) the black woman survived.
When you narrow it all down Ms.Boof, the only thing over-emphasized in this world is one's physical outer shell, which race really is. However, what's INSIDE the shell is a little more complex.
anyway, I wish you wellness.
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Kola
Moderator
Username: Kola
Post Number: 1529
Registered: 02-2005
Rating: N/A
Votes: 0 (Vote!) | | Posted on Friday, June 17, 2005 - 10:30 pm: |
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No, Roxie, I wasn't clear.
The baseball player's daughter could not be matched (for kidney, bone marrow whatever)---because of the JEWISH mother and BLACK father's blood types when mixed together, produced a deviant Blood Type that is COMMON to Middle Eastern Jews of African JEWISH-White Jewish ancestry--whereby they have a special plasma disfunction, similar to Low Platelets/White Cells.
In other words...those two "types" of PEOPLE are different.
It has nothing to do with being "Bi-racial"
....but it begs the question that all people are NOT one monolithic race, which was my point.
Yes, I am from SUDAN. I have two "blood" conditions, both of which are mostly harmless to me.....Sickle Cell Trait (an African disease that afflicts the ENTIRE continent--and which is why we eat YAMS to control it).........and I also
have a GREEK blood disorder called "POLYCYTHEMIA".
I don't know what Greek ancestors I had. I only know of my Egyptian father's Turkish-Kshan-Fallasha(Hebrew) and my Somali mother's Oromo-Waaq.
So it's strange that I carry "POLYCYTHEMIA"...but I was told by a doctor in London that many "Black" Egyptians have it, so it must be from my father's line.
AND PLEASE...call me KOLA.
I don't like being called "Ms. Boof".
I'm not THAT old. (I would put a smilie here, but I don't know how)
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Abm
"Cyniquian" Level Poster
Username: Abm
Post Number: 3445
Registered: 04-2004
Rating: N/A
Votes: 0 (Vote!) | | Posted on Friday, June 17, 2005 - 11:26 pm: |
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People have physiological differences. Thus, I believe it wonder that drug companies are attempting to address those difference.
The problem, though, I foresee what there're attempting to do is that AA's are so mixed that it seems unlikely drugs can be devised that can be safely/effectively/equally utilized amongst ALL of us.
Kola,
I think you're referring to the great Hall of Fame Major Leaguer hitter Rod Carew (I think the last team he played for was your nearby Anaheim (then California) Angels. Carew was one of my favorite athletes when I was a kid. I'm sorry to hear about his daughter. |
Kola
Moderator
Username: Kola
Post Number: 1530
Registered: 02-2005
Rating: N/A
Votes: 0 (Vote!) | | Posted on Friday, June 17, 2005 - 11:35 pm: |
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Let me attract you all to a DIFFERENT KIND of "genocide" going on now in Sudan:
http://www.thumperscorner.com/discus/messages/179/5822.html?1119065642
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roXie
Unregistered guest
Rating: N/A
Votes: 0 (Vote!) | | Posted on Friday, June 17, 2005 - 11:54 pm: |
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I didn't mean to offend you. I was taught(read:programmed) to address people who are older than me(by 3 yrs or 30) as "Mr." or "Ms." as a gesture of respect. but I'll call you "Kola", Kola.
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roXie
Unregistered guest
Rating: N/A
Votes: 0 (Vote!) | | Posted on Saturday, June 18, 2005 - 12:16 am: |
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hmm, I guess certain blood types can make for bad mixtures. Do they have special transplants for those people in the region where the blood type is common?
And what kind of Jewish ethnicity was the woman? yemeni? spanish? persian? Lemba?Uzbek? adopted korean? ;) I've never seen the wife so I keep automatically picturing a eastern-european woman in my head.
If she was of ME or med. descent, the daughter's blood type would really make sense then. |
Kola
Moderator
Username: Kola
Post Number: 1534
Registered: 02-2005
Rating: N/A
Votes: 0 (Vote!) | | Posted on Saturday, June 18, 2005 - 12:24 am: |
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Roxie, you didn't offend me.
The woman was Jewish from an Eastern Israeli stock--I believe Caananite.
And NO---they can't have any body transplants in that region when the African Jewish blood is mixed with the Caucasian Jewish blood.
I wish I knew more about it---because it doesn't preclude European Jews from mixing with African Jews---and IRANIAN JEWS can also mix with African Jews without the "trick" blood type occurring. It was very bizzare, but I don't recall all the details.
The wife was White, but it had nothing to do with bi-racial.
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roXie
Unregistered guest
Rating: N/A
Votes: 0 (Vote!) | | Posted on Saturday, June 18, 2005 - 12:43 am: |
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--Let me attract you all to a DIFFERENT KIND of "genocide" going on now in Sudan: --
I wanted to post this on the "Sudan" link but the board won't let me so...:
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god, this is worst than the excuse they gave for not being able to read the nubian inscriptions: they needed to find a "rosetta stone" to help decipher the texts. Strange, considering they didn't need a "rosetta stone" to decipher Aztec hieroglyphs and mesopotamian cuneiform. And Rome conquered every land in it's reach EXCEPT Nubia beacause Queen Amanatori(sp?)and her army drove them back, but because the greek cleopatra is FAR more important to history -_-, no one will ever know about this TRUE black Queen. And more will be lost if those pyramids are under water!
That was mostly a rant but I'm too angered to think straight. >
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Abm
"Cyniquian" Level Poster
Username: Abm
Post Number: 3456
Registered: 04-2004
Rating: N/A
Votes: 0 (Vote!) | | Posted on Saturday, June 18, 2005 - 07:57 am: |
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Kola,
The blood/genetic incongruities you cite provide sobering support for why we should proceed very CAUTIOUSLY about producing race-based drugs/treatments. |
Yvettep
"Cyniquian" Level Poster
Username: Yvettep
Post Number: 479
Registered: 01-2005
Rating: N/A
Votes: 0 (Vote!) | | Posted on Saturday, June 18, 2005 - 11:58 am: |
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I was at a conference recently where BiDil was one of the topics of conversation. One of the researchers responsible for the drug trial presented his findings...Later Dorothy Roberts fashioned a new orifice for him to defecate from.
I have many of the materials from the conference and could get them to folks who are really interested. In a nutshell, this particular clinical trial study has been accepted as "good science" so that is not the issue. These two point, however, are issues:
(1) BiDil is actually a combination of existing drugs on the market. Many conference participants questioned the motives of the drug company in rushing to find a new use for drugs before their patent runs out and it is able to "go generic." Folks were saying, why not let the drugs go generic, and educate doctors in prescribing the two pills in combination to help African American (and other) patients?
(2) And Roberts' main point: Other health care issues are responsible for far more fatalities from heart disease in the Black community that not taking a pill. Access to health care, money to pay for prescriptions, health insurance, racism and discrimination in the health care system, lifestyle, etc. Addressing these issues would likely be much more helpful in the longrun from patients suffering from various conditions. |
Yvettep
"Cyniquian" Level Poster
Username: Yvettep
Post Number: 480
Registered: 01-2005
Rating: N/A
Votes: 0 (Vote!) | | Posted on Saturday, June 18, 2005 - 12:09 pm: |
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Actually, I just checked and the videos from the conference are up: http://www.jointdegree.umn.edu/conferences/categories.php
Click on the AGENDA. Especially see the2:40 Q&A for Dorothy Roberts' comments about BiDil. Also, th 3:45 Q&A. The first questioner was kinda wacky, but Troy Duster's comments next are very insightful |
Kola
Moderator
Username: Kola
Post Number: 1543
Registered: 02-2005
Rating: N/A
Votes: 0 (Vote!) | | Posted on Saturday, June 18, 2005 - 01:10 pm: |
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I still find it ODD that there are certain drugs that work so much better for Blacks...than for others.
Not only this drug, but the recent AIDS drug (Was AIDS originally designed to kill blacks more effectively, I wonder?---Just being Paranoid).
There's also an ALZHEIMER'S drug being tested in Germany...that is said to frustrate scientists, because so far...it's only clearly up the minds of the AFRICAN testers, no one else.
Anyone believe the stories about BLACK "MS" sufferers (Richard Pryor, Lola Folana) living 20 years longer than White "MS" sufferers, and taking to the drugs better than their White counterparts?
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Abm
"Cyniquian" Level Poster
Username: Abm
Post Number: 3475
Registered: 04-2004
Rating: N/A
Votes: 0 (Vote!) | | Posted on Saturday, June 18, 2005 - 06:47 pm: |
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'Vette,
Thanks for posting the link to Robert’s query. I listen to ALL of it (I gottah love you eggheaded researcher types. ‘Cause you all are some ‘DIFF’RENT’ kinds of foks...Hehe!).
Now. What concerns me is it appears this BiDil thing is being made more into a political issue than a medicinal/health one.
What REALLY are we afraid of here: BiDil is being created as some kind of Black genocidal tool?
I don’t know. Parts of this appear pretty simple: Does the drug help foks, whom happen to be Black? If it does, what’s the beef?
Because the points Kola have repeatedly made about different response to drug/treatment bear acknowledging, if not obliging.
But in all the hubbub, it's difficult to discern whether this BiDil drug is beneficial.
Perhaps some objective, authoritative entity should conclude one of the following:
1) There’s proof the drug helps Black people without unacceptable side effects. If THAT’s true, .I’m say F#$% the detractors (Roberts notwithstanding) and support BiDil’s sale/distribution.
or
2) There is no proof the drug is especially helpful to us. In that case, I advocate it’s termination on THAT basis. Not just because BiDil was designed for Black foks. But because the $#*+ DON’T WORK!
I can agree with Roberts there probably are other methods of addressing AA heart issues. But that really isn’t relevant to the argument. Because it presupposed that if BiDil was terminated that all the dollars/efforts would be transferred to her preferred efforts. Which it WON’T (Not enough dough in it for the all-powerful pharmaceutical industry to do that).
Again, I think what may be proven as the BIGGEST problem with BiDil is few of us are purely Black. And our Blackness is itself mixed (as Kola has eloquently described elsewhere). Thus, it seems somewhat illogical to me that one drug could address the needs of ALL Blacks...unless Black cardiovascular/muscular systems are fairly congruent along ALL Black tribal origins.
PS: Also, I recall a year ago their being a lot of concern that a new form of asthma medication was being distributed could injury/kill Black people. I don’t know whether this was true or how it was resolved. But it seems to me that if there’re instances where Blacks might be uniquely harmed by a certain kind of medication, why couldn’t we be especially aided by another one? |
Kola
Moderator
Username: Kola
Post Number: 1564
Registered: 02-2005
Rating: N/A
Votes: 0 (Vote!) | | Posted on Saturday, June 18, 2005 - 07:11 pm: |
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ABM:
There was a recent AIDS drug that worked, miraculously, for BLACK patients--but not for most other races, with "ASIANS" being the second group to benefit the most.
*The drug worked even better on Africans than it did on African-Americans.
__________
So apparently, a drugs that works for Blacks had its best results on Africans----but still greatly benefitted U.S. Blacks (most of whom are still predominately of African blood)------so obviously, it would probably work for a Yellow Person who has 2 Black Parents.
And I would say that MANY "mixed" Blacks are still BLACK ENOUGH that the drugs would work.
Maybe not for Mariah Carey. But definitely for HALLE BERRY (who to me, is more black than white).
Who knows.
I saw some "Photos of Yellow skinned Black Americans" in the AIDS STUDY PICS, so they must mean people who are MOSTLY BLACK.
Now check this:
Because I have a GREEK blood disorder (POLYCYTHEMIA)....there are certain drugs that are made for my African blood disorder (Sickle Cell Trait)....that will NOT work for me.
And I'm BLACK with no knowledge of any Greek ancestors, whatsoever.
So there are probably variables.
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Kola
Moderator
Username: Kola
Post Number: 1565
Registered: 02-2005
Rating: N/A
Votes: 0 (Vote!) | | Posted on Saturday, June 18, 2005 - 07:17 pm: |
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YES---
there was an Asthma Mist that for some strange reason was fatal to BLACKS (and occasionally to Asians).
They took it off the market.
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Abm
"Cyniquian" Level Poster
Username: Abm
Post Number: 3478
Registered: 04-2004
Rating: N/A
Votes: 0 (Vote!) | | Posted on Saturday, June 18, 2005 - 07:24 pm: |
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Kola,
Thanks for the assist on the asthma mist.
I hope we can de-politicize this thing enough so that we at least KNOW whether or not the BiDil's of any benefit to us.
Because to me this whole thing is beginning to have the tone of 'throwing the baby out with the bath water." |
Yvettep
"Cyniquian" Level Poster
Username: Yvettep
Post Number: 494
Registered: 01-2005
Rating: N/A
Votes: 0 (Vote!) | | Posted on Sunday, June 19, 2005 - 09:54 am: |
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I gottah love you eggheaded researcher types. ‘Cause you all are some ‘DIFF’RENT’ kinds of foks...Hehe!
Yeah, I truly found my natural element when I found graduate school! My whole body was tingling at some of the heated exchanges at that conference--Talk about "battle of wits"! Great stuff...
BTW, I just wanted to make sure everyone was aware that Troy Duster is Black. He's really written some amazing stuff on this topic--quite a bit of it accessible to "lay" audiences and well worth the read.
And of course, most of you are probably familiar w/Dorothy Roberts' stuff. Her books (e.g., "Killing the Black Body," "Shattered Bonds") are very accessible and informative. I'd stay away from the law review articles, tho, unless you're into that particular brand of torture! |
Abm
"Cyniquian" Level Poster
Username: Abm
Post Number: 3497
Registered: 04-2004
Rating: N/A
Votes: 0 (Vote!) | | Posted on Sunday, June 19, 2005 - 10:13 am: |
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'Vette: "...My whole body was tingling at some of the heated exchanges..."
ABM: Yeah. I've had similar experiences while observing conferences. Though it mostly happens when the female speaker(s) is really HOT. |
Libralind2
"Cyniquian" Level Poster
Username: Libralind2
Post Number: 135
Registered: 09-2004
Rating: N/A
Votes: 0 (Vote!) | | Posted on Sunday, June 19, 2005 - 02:10 pm: |
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Thanks Kola for your concern about my foot pain..!!! It means a lot.
LiLi |
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